Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2019-04-01
2019-12-31
Brief Summary
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Detailed Description
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Method:
This study wants to establish the reference value of DNA gene variants of healthy control for comparing with the Sjögren's syndrome subjects. And the investigators want to use the DNA Exome sequencing tools, proteomics and oral microbiome to explore the association of gene expression between at least 30 Sjögren's syndrome subjects and at least 10 healthy control subjects. Finally, the investigators also analyze the association among gene expression, proteomics and oral microbiome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and heart rate variability (HRV) for this purpose.
Expected Results:
1. To evaluate the difference among TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and HRV for the Sjögren's syndrome and healthy control.
2. To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control.
3. To evaluate the proteomics for the Sjögren's syndrome and healthy control.
4. To evaluate the oral microbiome for the Sjögren's syndrome and healthy control.
5. To evaluate the association among the immunity-related gene expression, SSA, SSB and RF.
Keyword: Sjögren's syndrome, Immune regulation, Gene modulation, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, proteomics, oral microbiome
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Sjögren's syndrome
Sjögren's syndrome patients were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) primary or secondary SS; (2) aged between 20 and 75 years; (3) fulfilled the 2002 American-European Consensus Criteria for SS (AECG); (4) had no abnormal findings of immune, liver, kidney, or blood function evaluations. And the exclusion criteria were: (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition; (2) pregnancy or breastfeeding; or (3) steroid pulse therapy within three months prior to the commencement of our study.
DNA Exome sequencing
The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.
Oral microbiome
The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.
Proteomics
The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.
RNA sequencing
The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.
Cytokine
The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.
Traditional Chinese Medicine pattern
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.
Traditional Chinese Medicine tongue diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.
Traditional Chinese Medicine pulse diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.
Heart rate variability
Sjögren's syndrome patients and health subjects will take the heart rate variability.
Schirmer's test
Sjögren's syndrome patients will take the Schirmer's test.
Blood function test, liver function test, kidney function test, and immune function test
Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)
Health subjects
Health subjects were screened in the rheumatology outpatient departments and Center for Traditional Medicine at Taipei Veterans General Hospital, and were enrolled with the inclusion criteria: (1) aged between 41 and 63 years (which the age could match the SS patients enrolling in the SS-1 trial); (2) had no chronic inflammatory illness. And the exclusion criteria were: (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition; (2) pregnancy or breastfeeding; (3) abnormal findings of immune, liver, kidney, or blood function evaluations; (4) total sleeping time insufficiency less than 6 hours before one day of enrollment; (5) ever took the conventional medicine or hormone within one month; (6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.
DNA Exome sequencing
The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.
Oral microbiome
The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.
Proteomics
The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.
RNA sequencing
The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.
Cytokine
The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.
Traditional Chinese Medicine pattern
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.
Traditional Chinese Medicine tongue diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.
Traditional Chinese Medicine pulse diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.
Heart rate variability
Sjögren's syndrome patients and health subjects will take the heart rate variability.
Blood function test, liver function test, kidney function test, and immune function test
Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)
Interventions
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DNA Exome sequencing
The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.
Oral microbiome
The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.
Proteomics
The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.
RNA sequencing
The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.
Cytokine
The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.
Traditional Chinese Medicine pattern
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.
Traditional Chinese Medicine tongue diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.
Traditional Chinese Medicine pulse diagnosis
Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.
Heart rate variability
Sjögren's syndrome patients and health subjects will take the heart rate variability.
Schirmer's test
Sjögren's syndrome patients will take the Schirmer's test.
Blood function test, liver function test, kidney function test, and immune function test
Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)
Eligibility Criteria
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Inclusion Criteria
* (2) aged between 20 and 75 years
* (3) fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
* (4) had no abnormal findings of immune, liver, kidney, or blood function evaluations.
* (1) aged 20 and 75 years
* (2) had no chronic inflammatory illness.
Exclusion Criteria
* (2) pregnancy or breastfeeding
* (3) steroid pulse therapy within three months prior to the commencement of our study.
Health Subjects
* (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
* (2) pregnancy or breastfeeding
* (3) abnormal findings of immune, liver, kidney, or blood function evaluations
* (4) total sleeping time insufficiency less than 6 hours before one day of enrollment
* (5) ever took the conventional medicine or hormone within one month
* (6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.
20 Years
75 Years
ALL
Yes
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Principal Investigators
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Ching-Mao Chang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Locations
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Ching-Mao Chang
Taipei, Taiwan (r.o.c.), Taiwan
Countries
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Other Identifiers
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2017-09-006C#3
Identifier Type: -
Identifier Source: org_study_id
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